Rectal Diseases, Sigmoid Colon DiseaseExPeTuDNCT07241143
Extra-Peritoneal Tunneling Versus Conventional Drain Fixation After Anterior or Low Anterior Resection
A study testing EPT drain fixation and Conventional drain insertion in people with Rectal Diseases, Sigmoid Colon Disease and Rectal Cancer, Sigmoid Colon Cancer, run by Yeungnam University Hospital at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to learn whether the extra-peritoneal tunneling (EPT) drain fixation method works better and more safely than the conventional drain insertion method after rectal cancer surgery. It will also learn about the safety and possible complications of the EPT technique. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rectal Diseases, Sigmoid Colon Disease, Rectal Cancer, Sigmoid Colon Cancer
- What is being tested?
- EPT drain fixation and Conventional drain insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 596 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2025to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo rectal resection (anterior resection or low anterior resection) with planned intraoperative drain placement.
- Expected anastomotic level ≤10 cm from the anal verge based on preoperative imaging or endoscopic evaluation.
Who cannot join
- Patients scheduled to undergo additional colonic resection (e.g., right hemicolectomy, transverse colectomy).
- Patients in whom no intraoperative drain placement is planned.
- Patients scheduled for permanent or end stoma formation (e.g., abdominoperineal resection or Hartmann's procedure).
- Patients with prior pelvic surgery (e.g., hysterectomy, prostatectomy, pelvic lymph node dissection) that may cause pelvic adhesions or anatomic distortion.
- Patients with ASA physical status IV or severe systemic disease expected to require postoperative intensive care unit (ICU) admission.
- Patients who decline to provide informed consent for study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Efficacy and Safety of Extra-Peritoneal Tunneling Drain Fixation Versus Conventional Drain Insertion Following Anterior or Low Anterior Resection (ExPeTuD Trial): A Multi-Center Randomized Controlled Trial
The goal of this clinical trial is to learn whether the extra-peritoneal tunneling (EPT) drain fixation method works better and more safely than the conventional drain insertion method after rectal cancer surgery.
It will also learn about the safety and possible complications of the EPT technique.
Read more
The main questions it aims to answer are:
Does the EPT drain fixation method increase the success rate of conservative management (drain maintenance and/or antibiotics) when an anastomotic leak occurs?
Does the EPT method reduce the rate of drain displacement compared with the conventional method?
Are there any safety concerns or complications associated with the EPT method?
Researchers will compare EPT drain fixation to the conventional drain method to see which approach provides better outcomes after anterior or low anterior resection for rectal cancer.
Participants will:
Undergo anterior or low anterior resection for rectal cancer as part of their standard surgical treatment.
Be randomly assigned to either the EPT drain fixation group or the conventional drain group.
Receive the same postoperative care as usual, including follow-up imaging to monitor drain position and recovery.
Be observed for postoperative outcomes such as anastomotic leakage, drain position, and related complications until recovery.
This study will help determine whether securing the drain through an extra-peritoneal tunnel can prevent drain movement, improve early management of leakage, and enhance patient recovery after rectal surgery.
Read the detailed description
resection for rectal cancer. Although prophylactic pelvic drainage has been widely used to detect early leakage and to prevent pelvic sepsis, recent randomized trials and meta-analyses have reported that routine drain placement provides no significant benefit in reducing postoperative morbidity. One possible reason is drain displacement, which occurs in up to 30-40% of cases, resulting in the drain being positioned far from the anastomotic site and losing its intended function.
The extra-peritoneal tunneling (EPT) drain fixation method is a new surgical technique designed to prevent drain displacement by creating an extraperitoneal tunnel that anchors the drain securely near the anastomosis. This technique is performed using the Drain-TG™ (DTG) device developed by JSR Medical (Daegu, Korea). Preliminary retrospective data have shown that the EPT technique dramatically reduces drain displacement (2.8% vs. 40% with conventional insertion, p < 0.001) and that, in patients who developed AL, the success rate of conservative management (drain maintenance and antibiotics only) exceeded 80%, compared with 43% in the conventional group.
The ExPeTuD trial is a prospective, multi-center, randomized controlled trial that aims to establish strong evidence for the efficacy and safety of the EPT drain fixation method. Patients undergoing anterior or low anterior resection with a predicted anastomosis ≤ 10 cm from the anal verge will be enrolled from approximately 20 tertiary hospitals across Korea. Participants will be randomized 1:1 to either the EPT group or the conventional drain group, stratified by sex, tumor level (above vs. below the peritoneal reflection), and preoperative chemoradiation status.
The primary outcome is the success rate of conservative management (drain maintenance and/or antibiotics) for AL according to drain insertion method. Secondary outcomes include:
Rate and timing of drain displacement (defined as > 3 cm separation from the anastomotic site on X-ray),
Drain-related complications (infection, pain, bleeding, or organ injury),
Time to diagnosis of AL and time to re-intervention,
Postoperative recovery outcomes such as ileus, hospital stay, and overall morbidity (Clavien-Dindo classification).
Radiologic monitoring (abdominal X-rays on postoperative days 2, 4, and 6) will be performed to assess drain position, and additional imaging will be conducted if AL is suspected. Standard postoperative care, including enhanced recovery after surgery (ERAS) protocols, will be applied equally to both groups.
A total of 596 participants (298 per arm) will be recruited, which accounts for an expected 6% AL rate after low anterior resection and ensures sufficient power for superiority testing. Interim analysis will be conducted once ≥ 9 AL events occur in each group to assess safety and trial feasibility.
If the EPT drain fixation method proves effective in maintaining drain position and improving conservative management success rates, it could reduce the need for reoperation, shorten hospital stay, and improve patient outcomes after rectal cancer surgery. This trial aims to provide robust clinical evidence supporting the adoption of the EPT technique as a standard method for pelvic drainage following proctectomy.
- Being tested
- EPT drain fixation, Conventional drain insertion
- Keywords
- drain, anterior resection, low anterior resection
- Medical subject headings
- Rectal Diseases, Sigmoid Diseases, Rectal Neoplasms, Sigmoid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPT drain fixationProcedure or surgery
Participants in this arm will receive pelvic drain placement using the extra-peritoneal tunneling (EPT) drain fixation method after anterior or low anterior resection for rectal cancer. The drain is then passed through this tunnel and positioned close to the anastomosis to maintain stable drainage and prevent displacement
Conventional drain insertionProcedure or surgery
Participants in this arm will receive pelvic drain placement using the conventional transperitoneal method after anterior or low anterior resection for rectal cancer. In this standard technique, the drain is inserted directly through a lower abdominal port site (usually the left lower quadrant) into the pelvic cavity without creating an extraperitoneal tunnel
| Study group | Role | What they receive |
|---|---|---|
| Conventional drain insertion | Active comparator | Participants undergo standard transperitoneal pelvic drain placement following anterior or low anterior resection. Receives: Procedure: Conventional drain insertion |
| EPT drain fixation | Experimental | Participants undergo pelvic drain placement using the extra-peritoneal tunneling (EPT) method following anterior or low anterior resection. Receives: Procedure: EPT drain fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful conservative management in patients who developed an anastomotic leak
The success of conservative management is defined as resolution of the anastomotic leak without the need for reoperation or diversion. Success rates will be compared between patients managed with the Extra-Peritoneal Tunneling (EPT) drain fixation method and those with the conventional intraperitoneal drain placement.
Measured: Within 60 days after diagnosis of anastomotic leak
Secondary outcomes (5)
Incidence of drain displacement according to drain fixation method
Drain displacement is defined as any unintended displacement of the drain from the originally intended position, confirmed by radiologic verification (X-ray or CT). Drain displacement is defined as a drain-to-anastomosis shortest distance exceeding 3 cm on an radiologic imaging compared with the immediate postoperative position. Incidence (%) of displacement will be compared between the Extra-Peritoneal Tunneling (EPT) and conventional drain fixation groups.
Measured: Up to drain removal, an average of 7 days
Time to drain displacement (days)
Defined as the number of days from surgery to the date when drain displacement (drain-to-anastomosis shortest distance >3 cm on erect abdominal view) is first observed.
Measured: Up to drain removal, an average of 7 days
Incidence and types of drain-related complications according to drain fixation method
Includes any adverse events directly related to the drain, such as infection at the insertion site, pain, skin irritation, etc.
Measured: Up to drain removal, an average of 7 days
Early detection of anastomotic leak (days from surgery to diagnosis)
Evaluates whether the use of EPT drain fixation facilitates earlier identification of anastomotic leak. Measured as the number of days from surgery to the confirmed diagnosis of anastomotic leak.
Measured: Time to anastomotic leak, assessed up to 90 days after surgery
Interval between anastomotic leak diagnosis and reoperation (hours)
Measures the time interval between the diagnosis of anastomotic leak and reoperation, including documentation of whether the reoperation occurred as an emergency or elective procedure.
Measured: Time from leak diagnosis to reoperation, assessed up to 30 days after leak diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Diseases, Sigmoid Colon DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel-group, randomized controlled design to compare two surgical techniques for pelvic drain insertion following anterior or low anterior resection for rectal cancer. Participants will be randomly assigned in a 1:1 ratio to either the extra-peritoneal tunneling (EPT) drain fixation group or the conventional drain insertion group. Randomization will be stratified by sex, preoperative chemoradiation status, and the anastomotic level relative to the peritoneal reflection to ensure balanced distribution of clinical factors.
- Masking
- None (open label)
- Enrolment
- 596 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeungnam University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Konyang University Hospital, Daegu Catholic University Medical Center, Seoul National University Bundang Hospital, Samsung Medical Center, Seoul National University Hospital, Severance Hospital, Chungnam National University Hospital, Chungbuk National University Hospital, Keimyung University Dongsan Medical Center, Pusan National University Yangsan Hospital, Chonbuk National University Hospital, Kyungpook National University Chilgok Hospital, Yonsei University Yongin Severance Hospital, Chonnam National University Hospital, Ewha Womans University Seoul Hospital, Soonchunhyang University Hospital, Hallym University Dongtan Sacred Heart Hospital
- Responsible party
- Principal investigator, Sung il Kang, Yeungnam University Hospital
- Investigators
- SUNG IL KANG, M.D., Ph.D., Principal investigator, Yeungnam University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241143
- Sponsor's protocol ID
- 2025-08-031
- Acronym
- ExPeTuD
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not yet determined whether individual participant data (IPD) will be shared. If sharing is approved, only de-identified IPD related to primary and key secondary outcomes will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of Extra-Peritoneal Tunneling Drain Fixation Versus Conventional Drain Insertion Following Anterior or Low Anterior Resection (ExPeTuD Trial): A Multi-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07241143
- Acronym / sponsor ID
- ExPeTuD / 2025-08-031
- Keywords
- drain, anterior resection, low anterior resection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 596 participants (estimated)
- Lead sponsor
- Yeungnam University HospitalUniversity, hospital or other
- Collaborators
- Konyang University Hospital, Daegu Catholic University Medical Center, Seoul National University Bundang Hospital, Samsung Medical Center, Seoul National University Hospital, Severance Hospital, Chungnam National University Hospital, Chungbuk National University Hospital, Keimyung University Dongsan Medical Center, Pusan National University Yangsan Hospital, Chonbuk National University Hospital, Kyungpook National University Chilgok Hospital, Yonsei University Yongin Severance Hospital, Chonnam National University Hospital, Ewha Womans University Seoul Hospital, Soonchunhyang University Hospital, Hallym University Dongtan Sacred Heart Hospital
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether the extra-peritoneal tunneling (EPT) drain fixation method works better and more safely than the conventional drain insertion method after rectal cancer surgery.
It will also learn about the safety and possible complications of the EPT technique.
The main questions it aims to answer are:
Does the EPT drain fixation method increase the success rate of conservative management (drain maintenance and/or antibiotics) when an anastomotic leak occurs?
Does the EPT method reduce the rate of drain displacement compared with the conventional method?
Are there any safety concerns or complications associated with the EPT method?
Researchers will compare EPT drain fixation to the conventional drain method to see which approach provides better outcomes after anterior or low anterior resection for rectal cancer.
Participants will:
Undergo anterior or low anterior resection for rectal cancer as part of their standard surgical treatment.
Be randomly assigned to either the EPT drain fixation group or the conventional drain group.
Receive the same postoperative care as usual, including follow-up imaging to monitor drain position and recovery.
Be observed for postoperative outcomes such as anastomotic leakage, drain position, and related complications until recovery.
This study will help determine whether securing the drain through an extra-peritoneal tunnel can prevent drain movement, improve early management of leakage, and enhance patient recovery after rectal surgery.
Detailed description
resection for rectal cancer. Although prophylactic pelvic drainage has been widely used to detect early leakage and to prevent pelvic sepsis, recent randomized trials and meta-analyses have reported that routine drain placement provides no significant benefit in reducing postoperative morbidity. One possible reason is drain displacement, which occurs in up to 30-40% of cases, resulting in the drain being positioned far from the anastomotic site and losing its intended function.
The extra-peritoneal tunneling (EPT) drain fixation method is a new surgical technique designed to prevent drain displacement by creating an extraperitoneal tunnel that anchors the drain securely near the anastomosis. This technique is performed using the Drain-TG™ (DTG) device developed by JSR Medical (Daegu, Korea). Preliminary retrospective data have shown that the EPT technique dramatically reduces drain displacement (2.8% vs. 40% with conventional insertion, p < 0.001) and that, in patients who developed AL, the success rate of conservative management (drain maintenance and antibiotics only) exceeded 80%, compared with 43% in the conventional group.
The ExPeTuD trial is a prospective, multi-center, randomized controlled trial that aims to establish strong evidence for the efficacy and safety of the EPT drain fixation method. Patients undergoing anterior or low anterior resection with a predicted anastomosis ≤ 10 cm from the anal verge will be enrolled from approximately 20 tertiary hospitals across Korea. Participants will be randomized 1:1 to either the EPT group or the conventional drain group, stratified by sex, tumor level (above vs. below the peritoneal reflection), and preoperative chemoradiation status.
The primary outcome is the success rate of conservative management (drain maintenance and/or antibiotics) for AL according to drain insertion method. Secondary outcomes include:
Rate and timing of drain displacement (defined as > 3 cm separation from the anastomotic site on X-ray),
Drain-related complications (infection, pain, bleeding, or organ injury),
Time to diagnosis of AL and time to re-intervention,
Postoperative recovery outcomes such as ileus, hospital stay, and overall morbidity (Clavien-Dindo classification).
Radiologic monitoring (abdominal X-rays on postoperative days 2, 4, and 6) will be performed to assess drain position, and additional imaging will be conducted if AL is suspected. Standard postoperative care, including enhanced recovery after surgery (ERAS) protocols, will be applied equally to both groups.
A total of 596 participants (298 per arm) will be recruited, which accounts for an expected 6% AL rate after low anterior resection and ensures sufficient power for superiority testing. Interim analysis will be conducted once ≥ 9 AL events occur in each group to assess safety and trial feasibility.
If the EPT drain fixation method proves effective in maintaining drain position and improving conservative management success rates, it could reduce the need for reoperation, shorten hospital stay, and improve patient outcomes after rectal cancer surgery. This trial aims to provide robust clinical evidence supporting the adoption of the EPT technique as a standard method for pelvic drainage following proctectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a parallel-group, randomized controlled design to compare two surgical techniques for pelvic drain insertion following anterior or low anterior resection for rectal cancer. Participants will be randomly assigned in a 1:1 ratio to either the extra-peritoneal tunneling (EPT) drain fixation group or the conventional drain insertion group. Randomization will be stratified by sex, preoperative chemoradiation status, and the anastomotic level relative to the peritoneal reflection to ensure balanced distribution of clinical factors.
| Arm | Type | Receives |
|---|---|---|
| Conventional drain insertion | Active comparator | Procedure: Conventional drain insertionParticipants undergo standard transperitoneal pelvic drain placement following anterior or low anterior resection. |
| EPT drain fixation | Experimental | Procedure: EPT drain fixationParticipants undergo pelvic drain placement using the extra-peritoneal tunneling (EPT) method following anterior or low anterior resection. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled to undergo rectal resection (anterior resection or low anterior resection) with planned intraoperative drain placement.
- Expected anastomotic level ≤10 cm from the anal verge based on preoperative imaging or endoscopic evaluation.
Key exclusion criteria (6 listed)
- Patients scheduled to undergo additional colonic resection (e.g., right hemicolectomy, transverse colectomy).
- Patients in whom no intraoperative drain placement is planned.
- Patients scheduled for permanent or end stoma formation (e.g., abdominoperineal resection or Hartmann's procedure).
- Patients with prior pelvic surgery (e.g., hysterectomy, prostatectomy, pelvic lymph node dissection) that may cause pelvic adhesions or anatomic distortion.
- Patients with ASA physical status IV or severe systemic disease expected to require postoperative intensive care unit (ICU) admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPT drain fixationParticipants in this arm will receive pelvic drain placement using the extra-peritoneal tunneling (EPT) drain fixation method after anterior or low anterior resection for rectal cancer. The drain is then passed through this tunnel and positioned close to the anastomosis to maintain stable drainage and prevent displacement | Procedure or surgery | EPT drain fixation |
| Conventional drain insertionParticipants in this arm will receive pelvic drain placement using the conventional transperitoneal method after anterior or low anterior resection for rectal cancer. In this standard technique, the drain is inserted directly through a lower abdominal port site (usually the left lower quadrant) into the pelvic cavity without creating an extraperitoneal tunnel | Procedure or surgery | Conventional drain insertion |
Primary outcome
Rate of successful conservative management in patients who developed an anastomotic leak
Time frame: Within 60 days after diagnosis of anastomotic leak
The success of conservative management is defined as resolution of the anastomotic leak without the need for reoperation or diversion. Success rates will be compared between patients managed with the Extra-Peritoneal Tunneling (EPT) drain fixation method and those with the conventional intraperitoneal drain placement.
5 secondary outcomes
Incidence of drain displacement according to drain fixation method
Time frame: Up to drain removal, an average of 7 days
Time to drain displacement (days)
Time frame: Up to drain removal, an average of 7 days
Incidence and types of drain-related complications according to drain fixation method
Time frame: Up to drain removal, an average of 7 days
Early detection of anastomotic leak (days from surgery to diagnosis)
Time frame: Time to anastomotic leak, assessed up to 90 days after surgery
Interval between anastomotic leak diagnosis and reoperation (hours)
Time frame: Time from leak diagnosis to reoperation, assessed up to 30 days after leak diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Undecided. We have not yet determined whether individual participant data (IPD) will be shared. If sharing is approved, only de-identified IPD related to primary and key secondary outcomes will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SUNG IL KANG, M.D., Ph.D. principal investigator
Yeungnam University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPT drain fixation and Conventional drain insertion in people with Rectal Diseases, Sigmoid Colon Disease and Rectal Cancer, Sigmoid Colon Cancer, run by Yeungnam University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SUNG IL KANG, M.D., Ph.D. (+82-10-9124-5085, sungiry@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful conservative management in patients who developed an anastomotic leak (time frame: Within 60 days after diagnosis of anastomotic leak). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.